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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Department of Justice (DOJ) has announced that Wyeth Pharmaceuticals, now a subsidiary of Pfizer, has agreed to pay $491 million to settle allegations that it had unlawfully marketed the drug Rapamune, a kidney transplant drug, for unapproved uses in other organ transplant populations.

Under the Federal Food, Drug and Cosmetic Act (FD&amp;C Act), companies are only permitted to market a drug product for which they have received approval, and then are only permitted to market the drug for the exact indication for which it has been approved by the US Food and Drug Administration (FDA). Marketing drugs for different purposes or at different doses, known as "off-label" marketing-referring to the drug's FDA-approved labeling-is illegal, and violators may be subject to direct fines, as well as derivative fines related to reimbursement for the drug by federal programs like Medicare and Medicaid.

In a statement on 30 July 2013, DOJ staff said the settlement and others like it were intended to preserve the integrity of the regulatory process.

"The FDA approves drugs for certain uses after lengthy clinical trials," said Sanford Coats, US Attorney for the Western District of Oklahoma.&nbsp; "Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses."

Coats added that while FDA had approved Rapamune for limited use in renal transplants-and had specifically required a warning on the drug's label against use in other cases-Wyeth had "trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales."

Under the agreement, Wyeth has reportedly pleaded guilty to a misbranding violation under the FD&amp;C Act and will pay a $233.4 million criminal fine, $230 million in civil restitution to the US government, and $27.2 million to various state governments.